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Vertex-Dental BV

FDA UDI

Class I (US FDA UDI)

by Vertex-Dental B.V.

Identity

Trade Name
Vertex-Dental BV FDA UDI
Generic Name
Dental prosthesis veneer resin FDA UDI
Device Name
NextDent C&B MFH / N2 FDA UDI
Model / Reference
NDCMN201000 FDA UDI
Description
NextDent C&B MFH / N2 FDA UDI

Identifiers

Primary DI / UDI-DI
08719425503295 FDA UDI
FDA Product Code
DYT FDA UDI
GMDN Term
Dental prosthesis veneer resin FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Temporary dental crown/bridgeDental bridge, polymerTemporary dental crown/bridge resinDental prosthesis veneer resin

Vertex-Dental BV by Vertex-Dental B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made dental crown, polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vertex-Dental B.V.

Sources (1)

  • FDA UDI 1ac36252-6938-4056-8143-7bd6fca6d7ae 33 fields · synced May 30, 2026